Summary:
Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6033 - 42 C.F.R. 493.1409 Condition: technical consultant Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification records for the Sysmex XN-430 hematology analyzer and staff interview, it was revealed the laboratory failed to have documentation of retaining instrument printouts or results used to assess instrument accuracy. The findings include: 1. A review of the laboratory's verification records for the Sysmex XN-430 hematology analyzer (serial number 11471) performed in March 2021 revealed the laboratory assessed instrument accuracy by performing instrument comparisons of CBC (complete blood count) results to results obtained from another facility. The laboratory failed to have documentation of the instrument printouts or results from its instrument and from the other facility for review as part of the verification studies. 2. The laboratory was asked to provide documentation of the instrument printouts or results. No documentation was provided. 3. An interview with the technical consultant on 10/27/2022 at 1050 hours in the break room revealed the laboratory did not have the instrument printouts or results. This confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's policies, and staff interview, it was revealed the facility failed to have documentation of a policy which defined the requirements for competency assessments of the technical consultant. The findings include: 1. A review of the laboratory's submitted Form CMS 209 (signed by the laboratory director on 10/25 /2022) revealed the laboratory identified 1 technical consultant. 2. A review of the laboratory's policies revealed the facility failed to have documentation of a policy to define the requirements for competency assessments of consultants (clinical and technical). 3. The laboratory was asked to provide documentation of a policy. No documentation was provided. 4. An interview with the technical consultant on 10/27 /2022 at 1000 hours in the break room revealed the facility was unaware it needed a policy. This confirmed the findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)